510(k) · Cleared
ClearedLoss of Pulse Detection
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fitbit · SDY Loss Of Pulse Notification Software
Cleared on Feb 25, 2025 as substantially equivalent to K212372 (Fitbit, Inc., 2022) after a 152-day review. Its family tree reaches back 2 generations to 2018.
- Decided
- Feb 25, 2025
- Review
- 152 days
- Class
- Class II
- Product code
- SDY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN180042 (2018). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SDY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K212372 | Fitbit Irregular Rhythm NotificationsSummary page 5…Use Regulatory Class: Class II Product Code: SDY - 21 CFR 870.2790 3. Predicate Device Fitbit Irregular Rhythm Notifications (K212372) 4. Indications for Use Loss of Pulse Detection is a software-only mobile medical application that is intended to be… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All SDY devicesSDY Loss Of Pulse Notification Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SDY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SDY
Too few SDY 510(k)s in any year since 2007 to give a median.
Recalls per year · SDY
No recall names SDY since 2007.
Adverse event reports per year · SDY
No MAUDE report names SDY since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Loss of Pulse Detection is a software-only mobile medical application that is intended to be used with compatible consumer wrist-worn products to analyze pulse data to identify loss of pulse events and provide audio, visual, and haptic alerts to the user. If the user remains unresponsive to these alerts, Loss of Pulse Detection will attempt to prompt a call to emergency services through the user's connected compatible hardware, such as a smartphone or…
Read the full statement (218 words)
Loss of Pulse Detection is a software-only mobile medical application that is intended to be used with compatible consumer wrist-worn products to analyze pulse data to identify loss of pulse events and provide audio, visual, and haptic alerts to the user.
If the user remains unresponsive to these alerts, Loss of Pulse Detection will attempt to prompt a call to emergency services through the user's connected compatible hardware, such as a smartphone or smartwatch.
Loss of Pulse Detection is intended for over-the-counter (OTC) use. It is not intended to provide a notification on every loss of pulse event and the absence of an alert is not intended to indicate that no such event has occurred; rather the Loss of Pulse Detection is intended to opportunistically surface an alert of possible loss of pulsatility when sufficient data are available for analysis.
These data are only captured when the user is still. Loss of Pulse Detection is not intended to replace traditional methods of diagnosis, treatment, or monitoring.
Loss of Pulse Detection has not been tested for and is not intended for use in people under 22 years of age. It is also not intended for use in individuals previously diagnosed with a high risk for sudden cardiac death such as those with coronary artery disease, cardiomyopathy and/or unexplained syncope/fainting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242967 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242967: Loss of Pulse Detection.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242967
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026